Ultrasound-Guided stents may keep leg arteries open longer
NCT ID NCT05805280
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether using intravascular ultrasound (a tiny camera inside the artery) to guide stent placement in the leg is better than the usual X-ray guidance. One hundred people with blocked leg arteries were randomly assigned to one of the two methods. The goal was to see if ultrasound guidance leads to better blood flow and fewer repeat procedures after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intravascular ultrasound-guided stent implantation
- What this could lead to
- If successful, this approach could improve long-term blood flow and reduce the need for repeat procedures in people with blocked leg arteries.
- What could go wrong
- This is a small feasibility study, not a large definitive trial. The benefits seen may not hold up in broader testing, and ultrasound guidance adds complexity and cost.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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100 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men or women at least 20 years up to 85 years of age * Intermittent claudication or tissue loss suitable for elective endovascular intervention (Rutherford category 2,3,4, or 5) * Significant native superficial femoral or proximal popliteal artery lesions suitable for stent implantation. Restenotic lesions can be enrolled at least 12-month after the index procedure uding plain balloon or drug-coated balloon. * Total lesion length of 30 to 220 mm * Reference vessel diameter of 4 - 6 mm * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: * Existence of a stent in the target vessel * Previous use of atherectomy device in the target vessel * Use of drug-coated balloon in the target vessel within 12-month * Untreatable significant stenosis or occlusion (diameter stenosis ≥70%) in all 3 infrapopliteal arteries (patient can be enrolled if at least 1 patent outflow artery to the ankle (diameter stenosis \<50%) can be achieved by treatment during the index procedure) * A known intolerance or contraindication to antiplatelet drugs (aspirin or clopidogrel) * Unwillingness or inability to comply with the procedures described in this protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ajou University Medical Center
Suwon, South Korea
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Asan Medical Center
Seoul, South Korea
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Inje University Busan Paik Hospital
Busan, South Korea
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Kangbuk Samsung Hospital
Seoul, South Korea
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Konkuk University Medical Center
Seoul, South Korea
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Severance Cardiovascular Hospital
Seoul, South Korea
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Veterans Health Service Medical Center
Seoul, South Korea
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Veterans Hospital
Daegu, South Korea
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